Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053911
Status:
TERMINATED
Last Update Posted:
2014-12-16
First Post:
2003-02-05
Brief Title:
Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them after surgery may kill any remaining tumor cells following surgery It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of adjuvant cyclophosphamide epirubicin and fluorouracil vs observation in terms of disease-free 5-year survival in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery
Compare the overall survival of women treated with these regimens
Determine the tolerance of these women to the chemotherapy regimen
Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women
OUTLINE This is a randomized multicenter study Patients are stratified according to menopausal status and participating center Patients are randomized to 1 of 2 treatment arms Study begins within 42 days after resection of recurrent disease
Arm I Patients receive fluorouracil IV over 1 hour epirubicin IV over 1 hour and cyclophosphamide IV over 1 hour on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients then receive docetaxel IV over 1 hour on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients are examined on days 1 and 63
Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens depending on menopausal status
Oral tamoxifen daily for 5 years
Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone LHRH agonist therapy eg goserelin for 3 years
Oral LHRH agonist therapy eg goserelin for 3 years
Oral antiaromatase therapy eg anastrozole for 5 years Patients also undergo radiotherapy and may also undergo second complete resection
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 370 patients 185 per treatment arm will be accrued for this study within 3 years
Compare the efficacy of adjuvant cyclophosphamide epirubicin and fluorouracil vs observation in terms of disease-free 5-year survival in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery
Compare the overall survival of women treated with these regimens
Determine the tolerance of these women to the chemotherapy regimen
Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women
OUTLINE This is a randomized multicenter study Patients are stratified according to menopausal status and participating center Patients are randomized to 1 of 2 treatment arms Study begins within 42 days after resection of recurrent disease
Arm I Patients receive fluorouracil IV over 1 hour epirubicin IV over 1 hour and cyclophosphamide IV over 1 hour on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity Patients then receive docetaxel IV over 1 hour on day 1 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients are examined on days 1 and 63
Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens depending on menopausal status
Oral tamoxifen daily for 5 years
Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone LHRH agonist therapy eg goserelin for 3 years
Oral LHRH agonist therapy eg goserelin for 3 years
Oral antiaromatase therapy eg anastrozole for 5 years Patients also undergo radiotherapy and may also undergo second complete resection
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 370 patients 185 per treatment arm will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20237 | None | None | None |
| FRE-FNCLCC-PACS-03003 | None | None | None |